BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2843426 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-06761
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION # 1627487-07262012-002-R. THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR. REPORT#: 1627487-2012-06762, 06763. IT WAS REPORTED THE PT EXPERIENCED OVERSTIMULATION AT THE IPG SITE AND SOON AFTER STIMULATION SHUT OFF. AN IMPEDANCE CHECK REVEALED INVALID IMPEDANCE. THE PT IS SCHEDULED TO UNDERGO X-RAYS AND FURTHER INVESTIGATION OF THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2880336

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS ANCHORS: MODEL 1192 (2)| IMPLANT: